Further information

This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Why should you Attend:

This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

Areas Covered in the Session:

System Risk Assessment

GAMP 5 "V"Model

21 CFR Part 11

Electronic Records/Electronic Signatures (ER/ES)

Security, Access, Change Control and Audit Trail

Policies and Procedures

Who Will Benefit:

Information Technology (IT) Analysts

IT Developers

IT Support Staff

QC/QA Managers and Analysts

Speaker Profile:

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Further information

Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
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